To Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Adults

Hypertension Clinical Trial

Official title:

An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period Phase 1 Study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04185090
• Other study ID #: ID-VARE-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 2020
• Est. completion date: April 2020

Study information

• Verified date: November 2019
• Source: IlDong Pharmaceutical Co Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designated to evaluate the pharmacokinetic interactions of valsartan, amlodipine besylate, rosuvastatin, and ezetimibe in healthy male volunteers.

Description:

An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period phase 1 study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety between ID1801 and ID1803 in Healthy Male Subjects

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy adult male volunteers aged 19 to 45 years

• Subjects who have over 50kg and BMI more than 18.5kg/m2 and less than 29.9kg/m2

• Males must be agree to practice a medically acceptable method* of birth control and will not donate sperm during the study.

• Subjects who provided written informed consent to participate in this study and voluntarily taken part in during the entire study period

Exclusion Criteria:

• Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease

• Subject with symptoms of acute disease within 28days prior to study medication dosing

• Medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug

• Drugs or other drugs (aspirin, antibiotics, etc.) that contain the following drug categories or components of the same strain have an overactive or clinically significant history of hypersensitivity:

• Subject with a history of drug abuse or urinalysis positive

• Subject with clinically significant active chronic disease

• Subject with genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.

• Genetic myopathic disorder or related family history

• Positive test results for HBs Ab, HCV Ab, Anti HIV(AIDS), RPR Ab

• Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)

• Subject who cannot take standard meal in hospitalization

• Present history of hypothyroidism or clinically significant assay

• Subjects who donated whole blood or partial blood within 2 or 1 month, respectively, prior to the first administration.

• Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing

• Smokers whose average daily smoking amount exceeds 10 cigarettes per day within 3 months before the first dosing day and those who can't quit from 48 hours before dosing to the time of the last blood sampling.

• Subjects who judged ineligible by the investigator

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

Intervention

Combination Product:
• ID1803
Amlodipine 10mg/Valsartan 160mg
• ID1801
Ezetimibe 10mg/Rosuvastatin Ca 20.8mg
• ID1803+ID1801
Amlodipine 10mg/Valsartan 160mg Ezetimibe 10mg/Rosuvastatin Ca 20.8mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IlDong Pharmaceutical Co Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt(Amlodipine, valsartan, rosuvastatin, free ezetimibe)	Amlodipine, valsartan, rosuvastatin, free ezetimibe: AUCt	0~72hours
Primary	Cmax,ss(Amlodipine, valsartan, rosuvastatin, free ezetimibe)	Amlodipine, valsartan, rosuvastatin, free ezetimibe: Cmax,ss	0~72hours
Secondary	AUCt(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCt, Cmax,ss	N-desmethyl rosuvastatin, total ezetimibe: AUCt	0~72hours
Secondary	Cmax,ss(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCt, Cmax,ss	N-desmethyl rosuvastatin, total ezetimibe: Cmax,ss	0~72hours
Secondary	Cmin,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)	amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Cmin,ss	0~72hours
Secondary	Tmax,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)	amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Tmax,ss	0~72hours
Secondary	t1/2(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)	amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: t1/2	0~72hours
Secondary	CLss/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)	amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: CLss/F	0~72hours
Secondary	Vd/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)	amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Vd/F	0~72hours
Secondary	PTF(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)	amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: PTF	0~72hours